PHE Ending: What You Need to Know

Introduction

I'm Scott Rattigan, founder of Functional Lawyer. Way back in March of 2020, there was a lot of excitement because the federal government, the administration, at that time, put into place a lot of waivers for the pandemic, declaring a Public Health Emergency (PHE). Since the PHE is ending on May 11, 2023, there is much you need to know so that you're in compliance with all the laws going forward after that date. Basically, things will go back to the permanent rules. If you've been relying on these waivers or temporary rules for the past three years, this video is for you because you don't want to get into trouble by not knowing the rules. While there are dozens of rules that are going back into place May 11, or shortly thereafter, I want to focus on the two that have the most impact for our community here in functional medicine. First is cross state/interstate practice of telemedicine, and second is prescribing controlled substances via telemedicine. 

Cross State/Interstate Practice

Let's talk about the cross state/interstate practice of telemedicine. Way back in March 2020, the federal government relaxed some of the Medicare rules for reimbursement. And as a federal law, many journalists took headlines that were “clickbait” (a journalist’s job is to get clicks), kind of saying, “Telemedicine is a ‘free for all.’” That wasn't exactly what the headlines said, but that's what a lot of practitioners interpreted that to mean without reading all the fine print in the article. Now even if they did read the fine print in the article, journalists aren't always the most detailed. They can't understand complex laws or regulations all the time. They just summarize what the press releases do. And so, many providers and Facebook groups and elsewhere were under the false impression that “Hey, we could just practice wherever we want.” That wasn't true. The federal government only has authority to relax federal laws. State licensing is based on state laws. So, there never was a “free for all” from interstate or cross state practice of medicine. Some states did put temporary waivers in place. Many of those had lots of fine print that made them almost ineffective, meaning it wasn't even worth the trouble to try to use them. But most of those, if not all, have expired. Most of them expired before 2023 even began.

The permanent rules for cross state practice of telemedicine say that you need to be licensed wherever the patient is located unless the very, very narrow exception applies. Long story short, on cross state practice of telemedicine, there never was a “free for all.” And now there continues to not be a “free for all” although there are many more states than before that allow these “special purpose telemedicine licenses.” The 16 states (many other states are considering implementing this in their legislative sessions right now in the spring of 2023) that are allowing you to do that are outlined in my book, The Practice of Telemedicine. There's a step-by-step process to get “special purpose telemedicine licenses.” They are better than full licenses because 

• they're cheaper most of the time, 
• they don't come with Continuing Medical Education (CME) requirements, 
• and they're faster to get. 

Prescribing Controlled Substances via Telemedicine

The second thing that you need to pay attention to when the PHE is over is prescribing controlled substances via telemedicine. Now remember, before the pandemic there was a requirement that you needed to see patients in-person once before you prescribed any controlled substances to them. That was the rule since at least 2008. It was a federal rule, and during the pandemic that rule was waived so many providers and practices started prescribing controlled substances via telemedicine-only visits. And that was okay for the past three years, but as of May 11, that is no longer okay. So, what can you do? 

First, the easiest way to go about it is to consider making all your patients come to see you at least once before you prescribe controlled substances. The biggest of which in our community is testosterone. Now those of you that prescribe more than that, great, but most of the time its testosterone as a sticking point. It's a Schedule III Controlled Substance under the federal rules. So, if that's the case, and you want to make it easy on yourself, just make sure everybody comes to see you in-person once. That's it. 

There are a few narrow exceptions as we outlined in the book, or you can look up the Ryan Haight Act of 2008. But most of those exceptions are not worth the time. Again, these exceptions are so narrow that they're not even effective for most people. However, in February the Drug Enforcement Administration (DEA) put out some proposed rules for prescribing controlled substances via telemedicine after the pandemic is over. These proposed rules are intended to bridge between the PHE waivers and a post-PHE environment and should be final here in the early spring before the pandemic is over. These proposed rules will create two new limited options for prescribing controlled substances via telemedicine without a prior in-person exam. They're more complex and restrictive than what was in place during the pandemic. So, the easiest way to follow all these rules is to do the in-person visit first. We'll talk about those two limited exceptions and some of the onerous recordkeeping that you must do to make those work for you. 

Ryan Haight Act of 2008

For background, the Ryan Haight Act of 2008, as we mentioned, put in place that federal in-person requirement before you can prescribe controlled substances, and the DEA was directed at that point, in 2018, to create a special registration for good faith practitioners that just want to practice telemedicine, allowing them to register with the DEA to prescribe via telemedicine. They haven't done so. It's been 15 years. And they say they've satisfied that requirement through these two new proposed rules which absolutely don't fit that requirement at all. It doesn’t look like that is coming anytime soon. So, for most of you, the best way to prescribe controlled substances in your telemedicine practice is to require an in-person visit. But there are two new options. So, let's talk about what those are. 

Virtual First

First is a virtual first process where a practitioner can issue an initial prescription for a controlled substance without having conducted an in-person exam of the patient, but only if the medication is a non-narcotic, Schedule III, IV, or V, or buprenorphine for treatment of Opioid Use Disorder (OUD), and the prescribed amount does not exceed 30 days. This is called a telemedicine prescription which has a special defined term under this new set of rules. Before any additional prescribing can happen after 30 days, the patient must come in-person anyways. To avoid having to worry about all that, just have them come in-person first, but we'll go through the process of what that looks like in a few minutes. 

Qualified Medicine Referral

The second way you can prescribe the telemedicine now after the PHE without an initial in-person exam conducted by you is if a qualified telemedicine referral process is in effect. This qualified telemedicine referral process is where a patient has an initial in-person exam with a practitioner, who is also DEA registered and licensed, who then subsequently refers the patient to a second practitioner, which would be you in this example. The second practitioner can have a telemedicine examination of the patient and prescribe a controlled substance without personally conducting the in-person exam of the patient. Under this referral process, the telemedicine practitioner, the second one, you, can prescribe Schedules II, III, IV, and V and narcotic-controlled substances. Compared to the Ryan Haight Act, these are expanded flexibilities to allow more telemedicine-based care, but again, they're more restrictive than what we've been used to for the past three years. 

Before we get into all the details of how those two exceptions work, we need to address what the rules are for patients that you saw for the very first time during the pandemic. What happens to them?

Pandemic First Time Patients

Can first time patients, seen by you during the pandemic, be grandfathered in? Do they have to come in and see you in person? What's the rule? The Controlled Substances Act and these rules do not have any features allowing a grandfathering in from the in-person requirement. It's going to expire on May 11. That means any new patients that come in on May 12 or after must be seen, by you, in-person before you can prescribe. There is a kind of a grace period that's happening. The proposed rules call this “a telemedicine relationship established during the COVID-19 public health emergency.” Such a relationship exists if between March 16, 2020, and May 11, 2023, the PHE period, the practitioner prescribed a controlled substance based solely on a telemedicine encounter, and you never conducted an in-person exam of the patient. If that's the case, DEA will extend the in-person exam waiver an additional 180 days making the new in-person requirement sometime in November of 2023. For any prescribing after that date, the practitioner must either conduct an in-person exam, meet a different telemedicine exception under the Ryan Haight Act, or stop prescribing for that patient. Now, significantly if you see a new patient after May 11, that 180-day period doesn't apply. It's only for relationships established prior to May 11. So, you have 180 days to continue prescribing. After that, you must see them in-person or pass them off to a practitioner who can see them in-person or continue their prescription in a way that fits.

Virtual First Process

The virtual first telemedicine prescription is option number one where you conduct a telemedicine visit first, and then you can prescribe non-narcotics up to 30 days for Schedules III, IV, & V or buprenorphine. Under this process, the practitioner can issue an initial telemedicine prescription without the in-person exam. Here is the process. 

• DEA registered practitioner conducts the telemedicine exam of the patient. You've never had an in-person exam with this patient. 
• You must review and consider the Prescription Drug Monitoring Program (PDMP) database and the state where the patient is located if that state has one. You need to check for any controlled substance prescriptions for the past year, or if less than a year of data is available, the entire period. 
• If you're unable to obtain the PDMP data, then you may issue the prescription for no more than a seven-day period. Then you must subsequently check the PDMP data in case it's been refreshed. And you must record all attempts to obtain that data. If you fail to obtain the required PDMP data, you must record the dates and times you attempted to gain access, the reason why you were not able to gain access, and any follow-up attempts you made to gain access. 
• Once that's taken care of, the practitioner can issue an initial prescription but only for non-narcotic Schedules III, IV, & V or buprenorphine for treatment of OUD. A prescription is limited to a maximum of 30-day supply, after which time you must see them in-person or pass their care on to somebody who can. You must impose a notation on the face of the prescription or within the prescription order if it's an electronic prescription that has been issued via a telemedicine encounter. All prescribing must be done for legitimate medical purpose done in the usual course of your professional practice and in compliance with other state and federal laws. 
• After 30 days, you can conduct an in-person exam, you can participate in a three-party-exam, (patient, in-person practitioner, and the telemedicine practitioner simultaneously), or the patient can go to a different DEA registered practitioner for an in-person exam, and then that practitioner can send a qualifying telemedicine referral back to you. (We'll cover qualifying telemedicine referrals in option two under the new rules next.) If one of those three options is met, the telemedicine practitioner, the initial one that did the 30-day supply, can continue prescribing controlled substances without additional in-person exams, so long as doing so is within the legitimate medical purposes and no subsequent evaluation is required by other law. 

That is option one and as you can see there are many requirements. So, let's go into option two, which is qualifying referral process. 

Qualifying Telemedicine Referral Process

Qualifying telemedicine referral means a referral to a practitioner that's predicated on a medical relationship that exists between a referring practitioner and a patient where the first referring practitioner has conducted at least one medical evaluation in-person. In simpler terms, here's how a qualifying telemedicine referral process would work.

• The DEA registered practitioner sees the patient in-person and conducts the in-person exam in accordance with applicable state law. 
• That practitioner refers the patient to a second practitioner, you, in this case, for a legitimate medical purpose in the ordinary course of his or her practice. That first practitioner must make a written referral containing very specific content and send it to the second practitioner. 

• The second practitioner then will conduct a telemedicine exam of the patient. It need not occur at the same exact time, but it can be done later. The second practitioner need not conduct an in-person exam. 
• The second practitioner must still review and consider the PDMP database in the state where the patient is located. Again, if you are unable to obtain the data, you must not issue the prescription for no more than seven days while continuing to try to access the PDMP system in that state. 
• The second practitioner can prescribe a controlled substance including Schedule IIs and narcotics, but the practitioner must impose a notation on the face of the prescription or within the prescription order if prescribed electronically that it's been issued via a telemedicine encounter. 

As you can see, there are several steps to be followed if you want to use that referral process. It has special documentation and timing rules. A written referral must be based on diagnosis, evaluation, or treatment as a result of the in-person medical evaluation. The referring practitioner must communicate the results of the in-person evaluation by sharing the medical record. The written referral must also include the name and National Provider Identifier (NPI) of the referring practitioner and the name and NPI of the telemedicine practitioner, the second one. This means the referring practitioner can't just say go to “X” functional medicine. He or she must say you need to go to Dr. Jane Smith, NPI 123456789, specifically knowing that person’s NPI number. 

Summing Up Controlled Substances

So, to sum everything up, prescribing controlled substances at the end of the pandemic (the end of the PHE) requires an in-person exam before you can issue a prescription for a controlled substance. If you can meet one of the narrow exceptions the DEA has just come out with (and it's about to finalize), then you can issue prescriptions without an in-person encounter first. The first exception is virtual first telemedicine prescription; it’s limited to 30 days; you must check the PDMP database and make sure that the patient isn't abusing drugs. It's limited to Schedules III, IV, & V non-narcotics and buprenorphine. The other exception is with a qualifying telemedicine referral, and it has lots of rules and regulations around it as well. But if you can fit into either of these two exceptions, then you may issue at least an initial prescription via telemedicine, or then you as the second provider, the referred to provider, may issue controlled substances subsequently, after the proper referral process has been met.

Conclusion

Boy, it's a minefield out there for controlled substances. If you want to make it easy on yourself, just either have in-person visits or examinations with patients prior to prescribing controlled substances, or if you want to dig real deep on this qualifying telemedicine referral process and make that a part of your practice, then reach out to us at Functional Lawyer, and we can walk you through some of those regulations and requirements. 

If you want a full rundown on the permanent rules as they exist today in 2023, you can grab a copy of my book, The Practice of Telemedicine. It's available on Amazon. I'm giving out a free companion course.  After you purchase the book, go to functionallawyer.com/practice-of-telemedicine to get that companion course as well.

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